Kornimate/medical-research-clean huggingface dataset:
hyperglycemia in surgical infections

Conditions: Necrotizing Fasciitis

Summary: the primary purpose of this study is to evaluate two glycemic control regimens on clinical outcome in patients with necrotizing soft tissue infections. secondary aim is to evaluate the inflammatory and immune responses to the glycemic control regimens.

this is a multi-center explanatory trial of strict glycemic control for surgical patients with necrotizing soft tissue infection (nsti). the primary objective of this study is to verify feasibility of the intervention, provide unbiased and evidence-based estimates of treatment effects, and obtain data needed to design and direct a larger multi-center trial if necessary. the multi-center trial (n \>100) will have adequate power to identify a 30% difference in favorable outcome defined as discharge alive from the hospital without an amputation in less than the median number of hospital days. secondary objectives include evaluation of specific hypotheses relating the intervention to cytokine and neutrophil responses. these preliminary data will provide the basis for future research and grant applications, lend insight into the mechanisms by which hyperglycemia results in adverse effects, and improve outcome through the development of evidence-based therapeutic strategies for patient care.

Eligibility criteria:
inclusion criteria: * patients will be enrolled at one of the following centers: the lbj general hospital (ut-houston), the ben taub general hospital (baylor houston), the methodist hospital (texas medical center), or the university of texas health science center at san antonio and the brooke army medical center. * we will attempt to enroll all eligible patients with a diagnosis of a necrotizing soft tissue infection (nsti), including fournier's gangrene, confirmed in the operating room regardless of age, ethnicity or gender. exclusion criteria: * pregnant patients

Keywords: strict glycemic control
study of early hormone replacement therapy on risk factors for sudden cardiac death

Conditions: Menopausal Women

Summary: as an ancillary study to the keeps study (see clinicaltrials.gov identifier: nct00154180), the primary purpose is to measure effects of estrogen vs. placebo in menopausal women, on autonomic function and repolarization; both measured non-invasively via holter monitoring.

the parent study keeps, will be a randomized, placebo-controlled double blinded, prospective trial with two active groups and one placebo group. only patients enrolled in keeps will be invited to participate in this ancillary study.duration of the keeps study will be for 4 years after randomization for each study subject, with assessment of the primary endpoint, carotid cimt, twice at baseline, 12, 24, 36 and 48 months. ancillary to the keeps study, patients will undergo holter monitoring at baseline, 24 and 48 months.data will be analyzed after 24 and 48 months (corresponding to data analysis of the primary endpoints.) holter monitors will be put on during the scheduled keeps visits, will be worn for 24 hours and will be returned the following day. effects of estrogen on heart rate variability (hrv) and repolarization parameters will be evaluated, and also correlated with clinical, quality of life, sleep and mood information gathered through the parent study. anticipated enrollment from the parent study at this site is 90 study subjects. this ancillary does not involve the use of drugs or investigational devices.

Eligibility criteria:
inclusion criteria: * participant of the keeps parent study: clinicaltrials.gov identifier nct00154180 exclusion criteria: * non-participants of parent study

Keywords: menopause hormone replacement therapy sudden cardiac death
alster man and machine: comparison of manual and mechanical remote robotic catheter ablation for drug-refractory atrial fibrillation

Conditions: Atrial Fibrillation

Summary: long term results after pulmonary vein isolation (pvi) with robotic navigation in patients with drug refractory atrial fibrillation are not inferior to manual radiofrequency current ablation.


Eligibility criteria:
inclusion criteria: * paroxysmal atrial fibrillation * persistent atrial fibrillation \< 2 month * indication for catheter ablation * lef \> 50% * diameter la \< 50 mm exclusion criteria: * intracardial thrombus * atrial fibrillation with underlying curable disease * renal failure \> stage i * contraindication for anticoagulation * life expectancy \< 12 month * previous pvi * pregnancy

Keywords: pulmonary vein isolation robotic navigation atrial fibrillation
effects of zinc supplementation on anthropometric factors, apelin and inflammatory markers in obese individuals

Conditions: Obesity

Summary: to study the effects of zinc supplement on anthropometric factors, apelin and inflammatory markers in obese individuals, 50 obes person who referred to diet and nutrition clinic of shahid beheshti university of medical sciences will be randomly allocated to receive 50 mg zinc capsules or placebos for 15 weeks; both groups will be advised to adherence the investigators' diet . at the first and the end of the intervention,weight, body mass index (bmi), waist circumference, fat mass and lean body mass, concentration of zinc, albumin, hs-crp, tnf-α and plasma apelin will be assessed and compared between groups.


Eligibility criteria:
inclusion criteria: * age of 18 to 45 years * non-smoking * body mass index (bmi) more than 30 exclusion criteria: * pregnancy, lactation or menopause in women * history of liver disease, kidney, thyroid, diabetes and other metabolic diseases * use of drugs interfering with lipid profile, blood-thinning drugs, beta-blockers * patients with immune deficiency * use of zinc, calcium and iron supplement in the last 2 months * use of weight loss medication or special diet * following program to lose weight in recent 2 months * recent surgery
radiotherapy combined with endostatin and capecitabine for npc

Conditions: Nasopharyngeal Carcinoma

Summary: radiotherapy combined with recombinant human endostatin and capecitabine for patients with nasopharyngeal carcinoma (npc) resistant to induction chemotherapy.

this study was a single-arm, open-label, phase ii study of radiotherapy combined with recombinant human endostatin and capecitabine for patients with nasopharyngeal carcinoma (npc) resistant to induction chemotherapy. fourty-one patients of locally advanced npc resistant to induction chemotherapy were enrolled. patients received radiotherapy combined with recombinant human endostatin and capecitabine. the primary endpoint was recurrence free survival (rfs). secondary goals included overall survival (os), distant metastasis-free survival (dmfs), local-regional free survival (lrfs); adverse events (aes) and severe adverse events (sae); safety and quality of life (qol).

Eligibility criteria:
inclusion criteria: patients with newly histologically confirmed non-keratinizing (according to world health organization (who) histologically type). tumor staged as t3-4n1/n2-3 (according to the 8th american joint commission on cancer edition). no evidence of distant metastasis (m0). satisfactory performance status: karnofsky scale (kps) \> 70. adequate marrow: leucocyte count ≥4000/μl, hemoglobin ≥90g/l and platelet count ≥100000/μl. normal liver function test: alanine aminotransferase (alt)、aspartate aminotransferase (ast) \<1.5×upper limit of normal (uln) concomitant with alkaline phosphatase (alp) ≤2.5×uln, and bilirubin ≤uln. adequate renal function: creatinine clearance ≥60 ml/min. patients must be informed of the investigational nature of this study and give written informed consent. unsatisfactory tumor response (stable or progressive disease) after neoadjuvant chemotherapy (nact) exclusion criteria: who type keratinizing squamous cell carcinoma or basaloid squamous cell carcinoma. treatment with palliative intent. prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer. pregnancy or lactation. history of previous radiotherapy (except for non-melanomatous skin cancers outside intended rt treatment volume). prior chemotherapy or surgery (except diagnostic) to primary tumor or nodes. any severe intercurrent disease, which may bring unacceptable risk or affect the compliance of the trial, for example, unstable cardiac disease requiring treatment, renal disease, chronic hepatitis, diabetes with poor control (fasting plasma glucose \>1.5×uln), and emotional disturbance. satisfactory tumor response (complete response or partial response) after neoadjuvant chemotherapy (nact)

Keywords: nasopharyngeal carcinoma radiotherapy endostatin capecitabine
a 3-month open-label safety and efficacy study of tnx-102 sl tablets in fibromyalgia patients

Conditions: Primary Fibromyalgia

Summary: this is a phase 3, open-label, extension trial designed to evaluate the long term safety and efficacy over 3 months of tnx-102 sl tablets taken daily at bedtime for the treatment of fibromyalgia (fm). patients recruits into this trial are those who have successfully completed the double-blind studies; tnx-cy-f301 and tnx-cy-f302. patients will not be made aware of the therapy they received during the double-blind study.

the study consist of 4 study visits, including screening/baseline visit 1 (day 1, which is anticipated to be the same date as visit 6 in f301 or f302) and visits after 1, 2 and 3 months of treatment (visits 2-4). primary: the primary objective of the study is to evaluate the safety of tnx-102 sl tablets taken daily at bedtime over an additional 3 months in patients with fm who have completed the double-blinded lead-in study secondary: the secondary objective is to evaluate the efficacy of tnx-102 sl tablets taken daily at bedtime to control symptoms of fm

Eligibility criteria:
inclusion criteria: * the patient met all prior inclusion and exclusion requirements for study f301 or f302 originally, and has had no intervening medical conditions, increased suicidal ideation, or requirements for concomitant medications that preclude exposure to tnx-102 sl or enrollment in the extension study. * the patient completed expected dosing in f301 or f302 defined as taking study medication up to week 12, with at least 70% compliance with medication usage (based on overall drug accountability reconciliation at the end of the f301 or f302 lead-in study) and no major protocol deviations. * the patient has provided written informed consent to participate in this extension protocol. exclusion criteria: * none

Keywords: tnx-102 sl bedtime sublingual 3-month long term safety long term efficacy fibromyalgia
a study to evaluate efficacy and safety of three w0027 regimens in the treatment of moccasin type tinea pedis (mttp)

Conditions: Tinea Pedis

Summary: in this phase ib, multi-centre, randomized, double-blind, placebo-controlled parallel group study, 120 subjects with moccasin type tinea pedis (mttp) will be enrolled at approximately 11 centres in the usa, canada and australia. the primary objective of the study is to assess the patient response to three w0027 regimens in subjects with mttp. secondary objectives include assessment of the safety, tolerability and skin and nail pharmacokinetics to the three albaconazole regimens.


Eligibility criteria:
inclusion criteria: * subjects aged 18-65 years, who have been diagnosed with moccasin type tinea pedis (by positive dermatophyte culture, positive potassium hydroxide/calcofluor white preparation, and a total signs and symptoms score of at least 4). * females of childbearing potential must use contraceptive methods . exclusion criteria: * subjects who are receiving any cyp3a substrates with potential for qt prolongation; * have used systemic antifungal drugs within 30 days of first dose; or topical antifungals within 2 weeks of first dose. * also excluded are those who have a clinically significant medical condition.
randomized trial of immediate versus early and selective invasive percutaneous coronary intervention in nstemi

Conditions: Myocardial Infarction

Summary: in non-st-elevation the optimal time of percutaneous coronary intervention (pci) is unclear. some studies showed benefit of very early pci, some others early pci between 12-48 hours and others even showed a benefit of a selective invasive approach only in case of recurrence of symptoms or a positive stress test. the optimal timing of intervention is still matter of debate as a result of a randomized clinical trial.

in this randomized, controlled, open-label clinical trial we compare a very early cardiac catheterization (\< 2,5 hours after randomization) similar to st-elevation myocardial infarction treatment, versus an early invasive approach (within 2-48 hours after randomization) versus a selective invasive approach in patients with non-st-elevation myocardial infarction. all patients are treated with heparin, asa, clopidogrel loading dose (600 mg) with subsequent 75 mg/d and tirofiban for 24 hours.

Eligibility criteria:
inclusion criteria: 1. clinical symptoms: instable angina pectoris: * angina at rest \< 24 hours * new onset worsening angina within the last weeks with angina at very low threshold \< 24 h 2. troponin t: troponin t-elevation ≥ 0,03 μg/l 3. informed consent exclusion criteria: 1. age \< 18 years 2. age \> 90 years 3. stemi 4. hemodynamic instability 5. cardiogenic shock 6. warfarin therapy 7. contraindications for gpiib/iiia-inhibitors 8. life expectancy \< 6 months 9. known high bleeding risk 10. pregnancy 11. other reasons for troponin-elevation: myocarditis, secondary after hypertensive crisis, cardiac decompensation 12. no informed consent

Keywords: nstemi infarction treatment percutaneous coronary intervention non-st-elevation myocardial infarction
a cross over case control study of a vibration positional device for treatment of osa

Conditions: OSA

Summary: positional therapy is considered as a kind of conservative treatment especially for patients with osa which varies with body positions, and has been reported to be useful in selected cases especially those with positional osa. positional osa is present when the overall apnea hyponea index (ahi) is \> 5/hr with a supine ahi being more than 2 times of ahi in other positions, in a symptomatic patient. there will be 2 groups of patients in this study. group 1 consists of patients with positional osa who refuse cpap or tolerate cpap poorly. they will be provided with a vibration device as treatment, which will be worn on the neck during sleep. this device senses the position of the patient during sleep. it will vibrate when the patient lies supine until the patient turns laterally, thus prevents the patient to lie flat during sleep and reduce the severity of osa. it will be switched on and off for a period of 15 days alternatively with sleep study performed at the end of each period respectively to determine its efficacy in the on and off mode. there will be a wash out period of 1 week in between the on and off period to remove any residual effect. group 2 consists of patients with positional osa who are using dental device but response or tolerated poorly. they will use the vibration device with dental device together as dual therapy, to assess the role of combination therapy. the device will be operated in on and off mode with sleep study being performed in a similar manner as in group 1. informed consent will be signed. each participant will have 2 sleep studies performed at home, which will be supported technically by technician visiting their home for hook up of necessary equipment.


Eligibility criteria:
inclusion criteria: 1. patients with position dependent osa which is defined as supine ahi \>2 times the ahi in other positions, while an overall ahi \>5/hr. 2. patients who cannot tolerate/not using cpap. 3. patients who are on dental devices but residual ahi is \> 15 and symptomatic. 4. patients consent to study and able to follow the instruction of using positional device and home sleep study device. exclusion criteria: 1. patients with pregnancy. 2. patients who refuse home sleep studies. 3. patients with parasomnias. 4. patients who cannot follow the instruction of using positional device or home sleep study device. 5. patients who tolerate cpap well with good treatment outcome. 6. patients on dental device with good symptoms improvement and residual ahi \< 15/hr
effect of kinetic chain exercises on muscle strength, joint position sense and quality of life in children with haemophilia.

Conditions: Hemophilia a; Muscle Strength; Joint Position Sense; Quality of Life (QOL)

Summary: the goal of this clinical trial is to learn if there are effect of close kinetic chain exercises on muscle strength, joint position sense and quality of life in children with haemophilia? null hypothesis it will be hypothesized that: there is no effect of close kinetic chain exercises on muscle strength, joint position sense and quality of life in children with haemophilia.

sample size estimation will be carried out to determine the recruited number of children selected randomly from out patient clinic of atfal misr hospital, cairo governorate to participate in this study. the study targets male children with hemophilia a. they will be selected based on the following: inclusion criteria: 1. their chronological age will be 5-7yeasr. 2. all children will receive prophylaxis therapy. 3. they will able to stand and walk independently. 4. they will be able to follow instructions during evaluation and treatment. exclusive criteria: the children will be excluded if they have one of the following: 1. visual or auditory problem. 2. radiographic changes as bone erosions, destruction, or joint subluxation, or congenital or acquired skeletal deformities in both lower limbs. 3. surgical procedures performed six weeks prior to or during study. 4. bleeding in joint 2 week prior to assessment.

Eligibility criteria:
inclusion criteria: * 1. their chronological age will be 5-7yeasr. 2. all children will receive prophylaxis therapy. 3. they will able to stand and walk independently. 4. they will be able to follow instructions during evaluation and treatment. exclusion criteria: * the children will be excluded if they have one of the following: 1. visual or auditory problem. 2. radiographic changes as bone erosions, destruction, or joint subluxation, or congenital or acquired skeletal deformities in both lower limbs. 3. surgical procedures performed six weeks prior to or during study. 4. bleeding in joint 2 week prior to assessment.
effects of music and maternal voice on sedation depth and sedative use during pediatric magnetic resonance imaging.

Conditions: Pediatric Solid Tumor; Pediatric Brain Tumor; Pediatric Cancer

Summary: to evaluate the effects of music and maternal voice in children on sedation depth and sedative use during pediatric magnetic resonance imaging.

when the patients and their parents arrived in the magnetic resonance unıt about 30 minutes before the procedure, the anesthetist is obtained a medical history and carried out a physical examination and clinical assesment. patients were categorized into 3 groups: music, maternal voice and isolation. during the procedures,the patients in the music group listened to vivaldi's the four seasons violin concertos by sound isolating headphones, whereas the patients in the isolation group wore the headphones but did not listen to music. all patients were sedated by midazolam and propofol. during the procedure, an additional propofol was administered as required

Eligibility criteria:
inclusion criteria: * asa (american society of anesthesiologists) i-ii exclusion criteria: * patients with hearing impairment, distorted ear anatomy, recent organ or system deficiency, severe pulmonary and/or cardiovascular problems, intolerance to propofol, airway ab-normalities, or known psychiatric or mental problems were ex-cluded from the study.

Keywords: magnetic resonance sedation maternal voice sedative effects
adult oxytocin study

Conditions: Schizophrenia; Oxytocin; Social Cognition

Summary: in this study, investigators will examine the behavioral effects and neurophysiological mechanisms of the pro-social neuropeptide oxytocin in patients with recent-onset schizophrenia. such research is a necessary first step towards identifying whether intranasal oxytocin administration can serve as an adjunct treatment for social impairments in schizophrenia. aim 1: to quantify the effects of exogenous oxytocin on social cognition and behavior in patients with recent-onset schizophrenia. hypothesis a: patients and healthy comparison subjects will show enhanced social cognition (e.g., improved interpretation of paralinguistic and emotional cues, such as those involved in emotional or sarcastic communication) after administration of oxytocin versus placebo. hypothesis b: patients and healthy comparison subjects will show increased attention to others' eyes and patients will exhibit increased facial affect expressivity after administration of oxytocin versus placebo. aim 2: to examine the effects of exogenous oxytocin on persistent negative symptoms in schizophrenia (pns) activity in patients with recent-onset schizophrenia. hypothesis a: patients and healthy comparison subjects will demonstrate increased pns activity during social tasks after administration of oxytocin versus placebo. hypothesis b (exploratory): patients and healthy comparison subjects' improvements in social cognition and behavior will be predicted by the degree to which oxytocin increases their pns activity.


Eligibility criteria:
inclusion criteria for patients: * 18 to 65 years of age * english speaking * meet diagnostic and statistical manual (dsm)-iv criteria for schizophrenia, schizoaffective disorder, schizophreniform disorder. * no or at most only minor changes to medications in the past week * able to use nasal spray * must be capable of providing informed consent inclusion criteria for healthy volunteers: * 18 to 65 years of age * clinically stable * no diagnosis of mental disorder according to dsm-iv tr. * able to use nasal spray * must be capable of providing informed consent * english speaking exclusion criteria: * active substance abuse or dependence as determined by a urine toxicology drug screening * a current dsm-iv diagnosis of any disorder other than schizophrenia * medical conditions (atrophic rhinitis, recurrent nose bleeds and cranial-surgical procedures (hypophysectomy), congestion or sinus problems) that could interfere with the study as per the opinion of the investigator * hearing deficits * pregnancy * severe brain trauma

Keywords: oxytocin syntocinon social cognition schizophrenia